At least 10 million Americans suffer from urinary incontinence. The U.S. Department of Health and Human Services Clinical Practice Guideline: Urinary Incontinence in Adults has estimated that the annual cost of treatment exceeds $10 billion.
The most common forms of urinary incontinence are stress incontinence, urge incontinence and overflow incontinence. Stress incontinence is the most common type and is the result of pressure on the bladder during exercise, coughing, laughing or other body movements. Urge incontinence is the involuntary loss of urine due to an abrupt and urgent need to urinate. Overflow incontinence is leakage of small amounts of urine from a bladder that is always full.
The United States Department of Health and Human Service Clinical Practice Guideline divides the treatment of urinary incontinence into three major categories: pharmacologic; surgical; and behavioral.
An example of pharmacologic treatment is illustrated in U.S. Pat. No. 5,192,751 to Thor, incorporated herein by reference. Thor describes a method of treating urinary incontinence in a mammal which comprises administering an effective amount of a competitive NMDA antagonist.
The disadvantage of pharmacologic treatment such as that described in Thor is the possible side effects caused by the drugs used. Pharmacologic treatment is also inappropriate for long-term maintenance use and is not curative. Pharmacologic therapy for urge incontinence is designed to inhibit uncontrolled detrusor contractions. Drugs are usually effective in 80 to 85% of patients with uninhibited bladder contractions and symptoms of urinary frequency, urgency and incontinence. Anticholinergic medications are the mainstay of this type of treatment and the side effects common to this group of drugs include dry mouth, blurring of vision, constipation and drowsiness. For stress incontinence, the pharmacologic therapy is directed to the stimulation of certain receptors and muscles, including the internal sphincter. Drugs usually have only a 75% effective rate for patients with stress incontinence of a mild to moderate degree. Side effects from the drugs usually prescribed to treat stress incontinence can be severe and include headache, elevated blood pressure, nervousness, tachycardia and arrhythmia.
An example of surgical treatment is illustrated in U.S. Pat. No. 5,123,428 to Schwarz, incorporated herein by reference. Schwarz describes a method for implanting an artificial sphincter to control urinary incontinence in a patient including two implantation procedures and an intervening interval of testing and healing.
Surgical procedures are available for the treatment of certain physiological causes of incontinence. The major disadvantage of surgical treatment for urinary incontinence such as that described in Schwarz is the increased chance of infection and the risk of other complications as with any invasive surgical procedure. Another significant disadvantage of surgical treatment is that it is the most expensive method of treatment and, even though the procedure may not be successful in attaining continence, the effect may be irreversible.
Of the three treatment categories, behavioral treatment is the least invasive and least dangerous procedure for the patient. The objective of behavioral treatment is to reduce the chance of triggering an uninhibited detrusor muscle contraction or an incomplete closure of the sphincter muscle by regulating the frequency of voiding and preventing the bladder from being overstretched. Behavioral treatment has proven effective for patients suffering from urge, stress and mixed incontinence. However, patients with overflow incontinence are not primary candidates for behavioral intervention.
Various muscles control urination. Behavioral treatment for urinary incontinence focuses on the development of appropriate muscle contraction maneuvers involving certain of these muscles. Such treatment has been effective in controlling urinary incontinence and also is a non-invasive method with no side effects.
The detrusor and the internal and external sphincter muscles are the three structures responsible for storage and evacuation of urine from the bladder. Contraction of the internal sphincter prevents leakage of urine from the bladder. Dysfunction of one or more of these muscles is often the cause of incontinence.
Biofeedback is a behavioral training technique that is used to correct a host of physiological and psychological conditions. In the treatment of urinary incontinence, biofeedback measures a person's bodily response, amplifies that measurement, and provides visual and/or auditory feedback to the patient that allows the patient to observe the effect of appropriate muscular contraction maneuvers on the bladder.
It is possible to develop appropriate muscle contraction maneuvers without biofeedback. However, more than 80 percent of the patients treated for urge, stress or mixed incontinence are improved or completely continent after behavioral training with biofeedback. Furthermore, without biofeedback, it is possible that the patient will contract inappropriate muscles during treatment and, as a result, the patient may aggravate the incontinent condition. Thus, biofeedback is an important tool in restoring the proper function to a noncompliant bladder.
The use of biofeedback in connection with incontinence treatment usually involves inserting a catheter (FIGS. 1-3) or other sensory device into the bladder. With this procedure, as the bladder fills with water, the patient is able to use the biofeedback equipment to watch the recording of the increasing pressure in the bladder. The patient may experience some discomfort from the insertion or removal of the catheter or other sensory device and there is a 1 to 2 percent risk of infection from the catheterization.
Another technique using biofeedback in connection with incontinence treatment is described in U.S. Pat. No. 5,291,902 to Carman. The technique in Carman includes allowing the patient to use a portable electromyographic measuring unit which outputs a signal when the measurement is above a pre-set threshold value. A major disadvantage of this technique is that patients cannot receive contemporaneous instructions from medical personnel regarding their muscle contractions. A further disadvantage is that since patients only obtain a signal if the pre-set threshold is reached, levels of incremental improvement cannot be monitored, nor can any level of decline in muscle contractions be measured. Finally, since the measuring unit described in Carman uses only two electrodes, the sensitivity necessary to obtain meaningful information about the patient's activity can not be achieved.
A further technique described in Carman is neuromuscular stimulation. This technique is given in the form of repeated applications of electrical pulses to the appropriate pelvic floor muscles to cause them to repeatedly contract and relax. Such stimulation causes muscle growth and increased muscle strength. However, there are many drawbacks to the use of neuromuscular stimulation. One drawback with neuromuscular stimulation is that repeated intensive sessions are required in order for the technique to be effective. Another drawback is that the activity may overwork the muscles and result in debilitation, rather than strengthening. In addition, the electric pulses also may be painful to the patient. Finally, in order to attain sufficient stimulation to the pelvic floor muscles, the electrodes must be applied intrarectally or intravaginally. Thus, the technique may be considered invasive to the patient.
Thus, there are several problems with the current methods of treatment for urinary incontinence, such as (i) the drugs used in pharmacologic treatment may have side effects, (ii) surgical treatment is invasive, has risks of complications, and is painful, (iii) behavioral treatment without biofeedback may reinforce inappropriate muscle contractions, (iv) behavioral treatment with portable biofeedback equipment does not allow the patient to receive contemporaneous instructions from a physician or nurse, and (v) neuromuscular stimulation is invasive, may be painful and may cause inappropriate muscle activity.
One possible solution to these problems is to provide a method of treatment which does not utilize drugs with harmful or uncomfortable side effects, and that does not utilize surgical methods which can lead to infection.
Another possible solution to these problems is to provide a behavioral method of treatment wherein the EMG-BF equipment is used on the patient by medical personnel in behavioral training without the necessity of insertion and removal of the catheter.
Another possible solution to these problems is to provide a behavioral method of treatment wherein the patient, in addition to the medical personnel, may visually monitor the EMG-BF results.
Another possible solution to these problems is to provide a behavioral method of treatment in which the EMG-BF results are computed in "real-time" so that medical personnel can give contemporaneous instructions to the patient.
Another possible solution to these problems is to allow development of the appropriate muscle contraction maneuvers without neuromuscular stimulation.
Another possible solution to these problems is to provide a behavioral method of treatment which is less invasive than normal procedures and results in no patient discomfort and no risk of infection or other side effects.
Thus, there has been a need in the art for a less invasive behavioral method of treatment of urinary incontinence wherein EMG-BF equipment is used on the patient by medical personnel without the necessity of insertion and removal of the catheter and the biofeedback results are visually monitored by the medical personnel and the patient and are computed in "real-time" allowing contemporaneous instructions from the medical personnel and responses from the patient.